Using Digital Health Data to Engage Patients and Improve Clinical Trial Operations and Research
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By Ashley Murgatroyd, Senior Director of Life Sciences Product at Human API.
Current Challenges in Clinical Trial Operations and Research
Today, Life sciences organizations spend millions of dollars every year conducting clinical trials. The struggle to recruit and enroll the required number of patients in a clinical trial as quickly as possible is a well-documented challenge.
This is becoming even more challenging with the increase in prevalence of personalized and specialty medicines designed to treat rare and complex diseases that affect smaller, more specific patient populations which make recruitment even more difficult. Furthermore, many trials today are conducted with a participant pool that doesn’t reflect the diversity of the population that will actually receive the drug, leading to questions about effectiveness and safety in the real-world. Trials can also take years to complete, with very low probability of success.
The good news is that more technologies have become readily available today to help address these different challenges. From decentralized clinical trials products to clinical trial recruiting platforms, to solutions that provide population-level analytics and de-identified real world data sets, there are now more new tools than ever before to enable better clinical research.
But while there are technologies that can improve efficiencies of clinical trials operations and contribute to better research outcomes, there is still a big need for solutions that can both engage patients and also provide unified access to digitized medical data that streamlines participant recruitment and qualification.
Human API brings researchers and patients together in one platform
Human API helps Life Sciences organizations accelerate clinical research and better understand patient outcomes by enabling them to engage with patients directly to authorize access to digital health data from a nationwide network that covers over 270 million lives.
Human API gives patients a simple way to connect and share their health data for clinical research.
With Human API, patients are empowered to participate in the recruitment and research process by authorizing and sharing their health data, which results in rich, usable real-world datasets where new insights can be quickly derived and enrollment decisions can be made. To learn more about how Human API is accelerating clinical research and improving outcomes, read our blog on powering patient-centricity in life sciences.
Improving speed of screening & enrollment reduces research costs
It’s no secret that clinical trials can take a long time and be extremely costly to complete. Across Phases 1 through 3 and various therapeutic areas, the median time spent in the clinic ranged from 5.9 to 7.2 years for non-oncology trials and 13.1 years for oncology trials (reference). Delays are very common, with 70-80% of all clinical trials being delayed (reference). Furthermore, complex study designs can contribute to high screenfail rates - ranging from 20% for diseases that impact a wide population to 80%+ for rare diseases and each screen failure can contribute to additional study delays and increase in costs (reference). Overall, the cost is estimated to be $600,000 - $8 million for each day the drug is delayed to market (reference).
It’s extremely difficult and time-consuming to determine participant eligibility for a study and sites spend a lot of time and effort screening potential participants that don’t end up enrolling. Additionally, participants often travel a long distance to a site only to find out they don’t qualify for the trial. Finding a way to better engage patients and use digital health data to screen for participant eligibility can result in reducing the delay of bringing new drugs to market - which may contribute to millions in cost reductions over the lifespan of each clinical trial.
With Human API, life sciences organizations can start accessing usable digital health data to improve clinical operations today:
Reduce screen fails & site fatigue with structured digital health data. Human API enables potential participants to digitally share electronic health record (EHR) data during the pre-screening process to gain confidence in their eligibility, before making the decision of sending them to a site. This improves the site’s confidence in the patient referral and enables them to spend time screening participants who are more likely to enroll rather than screen fail.
Accelerate screening & enrollment with digital patient health data. Human API makes it faster and easier for sites to determine patient eligibility. All authorized EHR data from our platform, regardless of the data source, is presented in a consolidated format with reports focused on specific inclusion/exclusion criteria - helping sites make faster decisions and achieve the last patient in (LPI) sooner.
Improving diversity and inclusion in clinical trials is important in validating real-world effectiveness of study drugs
Inclusion of broad, diverse patient populations—for example, people of different races, ethnic groups, sex/genders, ages or those with rare conditions—help provide evidence that the study drug will be safer and more effective in the wider target patient pool in the real world, if the drug or device is approved. Despite this, many clinical trials today involve participants that don't reflect the diversity of the population that will actually receive the drug. For example, Black Americans make up more than 13% of the U.S. population. But in the clinical trials that led to FDA approval of four new breast cancer treatments in 2020, only 2% to 9% of participants were Black. Similarly, Hispanic or Latin Americans make up 18.5% of the U.S. population, but accounted for 0% to 9% of participants in those same trials (reference). An Industry Paper written by IQVIA researchers found that 0% and 27% of groups tested in multiple sclerosis and lung cancer trials respectively in 2021 were representative of the disease epidemiology in the US (reference). Additionally, Asian Americans and American Indian people have also been found to be underrepresented in clinical trials relative to the ratio they represent in the U.S. population (reference). This perpetual underrepresentation across all ethnic groups shows the lack of diversity and inclusion in current clinical trials today, which leads to uncertainty about the validity of the trial results and drug efficacy out in the real world.
Traditional trial designs limit diversity & inclusion as data related to racial, ethnicity, and social determinants of health (finances, physical activity, stress, etc.) are often not available to clinical researchers. Many clinical trial sites are also located far away from certain areas where diverse and underrepresented populations reside, further limiting their ability to participate. It’s known that 80% of cancer patients are not treated in academic centers, but in the community (reference). For this reason, many organizations have actually begun to leverage remote, virtual, and decentralized trial designs with the intent of bringing the research to the patient. This facilitates faster recruitment, better retention, and greater control, convenience, and comfort for the patient while improving overall diversity and inclusion which contributes to validating the real-world efficacy of study drugs. However, despite the technological infrastructure available to make this new trial design possible, efficient collection of RWD still remains a limitation.
With Human API, life sciences organizations can now:
Facilitate RWD collection for decentralized / remote trials. Enabling patients to visit sites/labs/and pharmacies closest to where they live and collecting RWD in real-time is imperative to good research outcomes. With our platform, researchers can compile rich datasets on potential participants and identify specific patients within targeted populations to ensure diversity targets are met.
Empower patients to get involved. Engaging the patient throughout the process with a patient-centric solution helps them feel like they’re part of the research journey. This empowers everyone, regardless of their background, to take control of their health data and participate in clinical research. With our platform, researchers can easily engage patients directly to share their data to participate and increase the diversity of trials.
Reduce cost, risk, and improve probability of success
According to a study published in 2020 by the Institute for Safe Medication Practices, the median cost for a pivotal clinical trial was $48M (reference) and previous studies have estimated average costs to be as high as $255M (reference). It’s hard to say where the actual costs fall within that range but no one can argue that conducting a clinical trial is a very expensive endeavor. It’s also risky. A vast majority of medicines that enter clinical trials don’t make it to market. The overall probability of success from Phase 1 to approval of a drug across all indications was 21.6% while oncology alone had an overall probability of success of 11.4% (reference). Furthermore, patient recruitment is responsible for 41% of delays (reference).
While many companies have attempted to address this challenge by leveraging vast de-identified datasets to identify providers that may treat the target populations, without the appropriate consents, targeted outreach to patients is not possible. Furthermore, the data used to model different trial designs is often limited to specific EHR systems and providers, or highly reliant on claims data which provides only a glimpse into the patient’s health history. To truly transform clinical trial operations - reducing cost, risk, and significantly improving the probability of success - life sciences organizations need a solution that offers robust, rich real-world data from a wide variety of sources combined with built-in patient consent. With Human API, life sciences organizations can:
Model trial designs to predict success. Leverage Human API’s extensive database of RWD from a wide variety of sources (EHR, claims, pharmacy, labs, wearables, etc.) and locations across the US to model different trial designs and predict recruitment success.
Build patient registries to accelerate recruitment in the future. Start building a rich, disease-agnostic patient registry with RWD through ongoing use of Human API across all trials. Incorporate the necessary consents into the patient engagement workflow to enable targeted outreach to patients for future trials.
With the right consents and tokenization technologies, life sciences organizations can also leverage Human API to create robust longitudinal datasets over time to fuel additional research (HEOR, synthetic control arms, label expansion, etc.). More on this in future blog posts.
Improving the Future of Clinical Trials and Research with Digital Health Data
The future of clinical trials will be patient-centric, transparent, and feel more seamless for both researchers and study participants. Improving the ability to access structured digital health data and engage patients is critical to accelerating the life sciences industry towards this desired state. There is already enough digitized medical data and technological capabilities available today to streamline how clinical trials are done so new drugs can be brought to market faster to treat diseases and make personalized medicine a reality across diverse patient populations. We’re excited to partner with life sciences organizations to improve clinical trial research and build a new ecosystem that allows patients everywhere to use their own health data to contribute to drug discovery and increasing human longevity.
References.
https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trial-delays/
https://www.appliedclinicaltrialsonline.com/view/can-recruitment-and-retention-get-any-worse
https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trial-delays/
https://www.breastcancer.org/research-news/minorities-underrepresented-in-cancer-research
https://www.iqvia.com/insights/the-iqvia-institute/reports/global-trends-in-r-and-d-2022
https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trial-delays/
